510(k) K070979
- Device
- PULL TAB SQUEEZE FLUSH
- Applicant
- ICU MEDICAL, INC
- 510(k) number
- K070979
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-19
- Date received
- 2007-04-06
- Regulation
- 870.1210
- Classification name
- Catheter, Continuous Flush
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TRACY BEST
- Address
- 4455 Atherton Dr. Salt Lake City UT US 84123 84123
FDA Registration Numbers#
- 1721686
- 9612051
- 1000121056
- 3020347218
- 3010041511
- 3027595864
- 3005160949
- 3031976597
- 1721676
- 3026567963
- 3008264254
- 2183870
- 1319639
- 1644312
- 8023054
- 3021067373
- 3040099838
- 3013858269
- 2246552
- 1928237
- 3006082230
- 3015225571
- 1724474
- 2244478
- 3010220595
- 9612501
- 3045042524
- 3004859241
- 3020256033
- 1721504
- 3013556777
- 3002807314
- 3007695959
- 2531321
- 2011171
- 1018233
- 3015309643
- 9616662
- 3031240343
- 3014787927
- 9681260
- 1000393132
- 3030733800
- 1319211
- 3017823876
- 2134812
- 3014211783
- 3008837339
- 3015151147
- 3009500972
- 2648729
- 3000126629
- 3006950086
- 3009756153
- 1225687
- 3033589330
- 8010026
- 3010909876
- 1718873
- 3030481118
- 3008824097
- 3039020025
- 3003120897
- 3004111573
- 3014590708
- 3012543881
- 3019807891
- 1220452
- 3007156625
- 3014162263
- 2029214
- 3013134719
- 8020616
- 3013391155
- 3006946276
- 3010047454
- 3004415014
- 3014687026
- 3015550451
- 3014644549
Source Documents#
Other 510(k) Records For Product Code KRA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | 2026-09-21 |
| K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2026-09-11 |
| K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026-06-11 |
| K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 |
| K250794 | InVera Infusion Device | Invera Medical | 2026-03-12 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Transit Scientific, LLC | 2023-11-29 |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | 2023-07-05 |
| K231148 | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical , Ltd. | 2023-06-20 |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023-05-02 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 |
| K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister | Argon Medical Devices, Inc. | 2023-04-10 |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 |
Legacy Summary#
summary
FDA Review#
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